MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4130, 5MMX35CM EPIX LATIS GRASP, 10/BX; LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC

Model Number C4130

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bowel Perforation (2668)

Event Date 02/11/2020

Event Type  Injury  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: lap subtotal hysterectomy and bso.Patient details: female; dob (b)(6).Dr [name] was assisting dr [name] case in a lap subtotal hysterectomy and bso; whilst using the grasper a small amount of small bowel was caught in-between the hinge of the epix grasper tips when the jaws were open and surgeon found it difficult to dislodge entrapped tissue and some bleeding occurred suggesting small injury occurred to the small bowel.Additional information was received via email from advanced procedure specialist, [name] on 14feb2020: i have spoken to [name] about this and unfortunately cannot confirm the below.Intervention: ni.Patient status: stable.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Engineering observed blood on the hinge and the rivet of the device and performed testing to replicate the reported event of tissue snagging.Based on the condition of the returned unit, it is likely that the tissue was caught on the rivet of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an unacceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has implemented design enhancements intended to further minimize the potential for this type of event to occur.Recall number: 2027111-03/11/20-002-r.

Event Description

Procedure performed: lap subtotal hysterectomy and bso patient details: female initials amf ; dob 1968.Dr [name]was assisting dr [name] case in a lap subtotal hysterectomy and bso; whilst using the grasper a small amount of small bowel was caught in-between the hinge of the epix grasper tips when the jaws were open and surgeon found it difficult to dislodge entrapped tissue and some bleeding occurred suggesting small injury occurred to the small bowel.Additional information was received via email from advanced procedure specialist, i have spoken to [name] about this and unfortunately cannot confirm the below.Additional information was received via email from advanced procedure specialist, no unfortunately, the meeting was called off due to covid-19 pandemic and changing to working from home conditions.Intervention: ni patient status: stable.

• Brand Name: C4130, 5MMX35CM EPIX LATIS GRASP, 10/BX
• Type of Device: LAPAROSCOPIC ACCESSORIES, GYNECOLOGIC
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9803203
• MDR Text Key: 186182185
• Report Number: 2027111-2020-00410
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: (01)00607915110147(17)220813(30)01(10)1366453
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: C4130
• Device Catalogue Number: 101472876
• Device Lot Number: 1366453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention